In the CARD study (NCT02485691), cabazitaxel significantly improved clinical outcomes versus abiraterone or enzalutamide in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel and the alternative androgen-signalling-targeted inhibitor.
However, some patients received docetaxel or the prior alternative androgen-signalling-targeted inhibitor in the metastatic hormone-sensitive (mHSPC) setting. Therefore, the CARD results cannot be directly translated to a Japanese population.
Patients (N = 255) received cabazitaxel (25 mg/m2 IV Q3W, prednisone, G-CSF) versus abiraterone (1000 mg PO, prednisone) or enzalutamide (160 mg PO) after prior docetaxel and progression ≤12 months on the alternative androgen-signalling-targeted inhibitor. Patients who received combination therapy for mHSPC were excluded (n = 33) as docetaxel is not approved in this setting in Japan.
A total of 222 patients (median age 70 years) were included in this subanalysis. Median number of cycles was higher for cabazitaxel versus androgen-signalling-targeted inhibitors (7 versus 4). Clinical outcomes favoured cabazitaxel over abiraterone or enzalutamide including, radiographic progression-free survival (rPFS; median 8.2 versus 3.4 months; P < 0.0001), overall survival (OS; 13.9 versus 11.8 months; P = 0.0102), PFS (4.4 versus 2.7 months; P < 0.0001), confirmed prostate-specific antigen response (37.0 versus 14.4%; P = 0.0006) and objective tumour response (38.9 versus 11.4%; P = 0.0036). For cabazitaxel versus androgen-signalling-targeted inhibitor, grade ≥ 3 adverse events occurred in 55% versus 44% of patients, with adverse events leading to death on study in 2.7% versus 5.7%.
Cabazitaxel significantly improved outcomes including rPFS and OS versus abiraterone or enzalutamide and are reflective of the Japanese patient population. Cabazitaxel should be considered the preferred treatment option over abiraterone or enzalutamide in this setting.
Japanese journal of clinical oncology. 2021 Mar 19 [Epub ahead of print]
Hiroyoshi Suzuki, Daniel Castellano, Johann de Bono, Cora N Sternberg, Karim Fizazi, Bertrand Tombal, Christian Wülfing, Meredith C Foster, Ayse Ozatilgan, Christine Geffriaud-Ricouard, Ronald de Wit
Department of Urology, Toho University Sakura Medical Center, Chiba, Japan., Medical Oncology Department, 12 de Octubre University Hospital, Madrid, Spain., Drug Development Unit, The Institute of Cancer Research and the Royal Marsden Hospital, London, UK., Division of Hematology and Medical Oncology, Englander Institute for Precision Medicine, Weill Cornell Medicine, New York, NY, USA., Department of Cancer Medicine, Gustave Roussy Institute and Paris Sud University, Villejuif, France., Division of Urology, Université Catholique de Louvain, Louvain, Belgium., Department of Urology, Asklepios Klinik Altona, Hamburg, Germany., Global Medical Affairs Oncology, Sanofi, Cambridge, MA, USA., Europe Medical Affairs Oncology, Sanofi, Paris, France., Department Medical Oncology, Erasmus University Hospital, Rotterdam, the Netherlands.